IMMUNOSCIENCE INDIA PVT. LTD.

FDA Device Registration & Listing · Pune Maharashtra, IN · Registration 3031699317

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031699317
FEI Number
3031699317
Entity Name
IMMUNOSCIENCE INDIA PVT. LTD.
City/State/Country
Pune Maharashtra, IN
Establishment Address
Gat no. 41, Kusgaon, Shivapur - Velhe Road, Tal - Bhor, Dist - Pune, Pune Maharashtra 412205, IN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
IMMUNOSCIENCE INDIA PVT. LTD. (Owner Number: 10090966)
Owner / Operator Contact Address
Gat no. 41, Kusgaon, Shivapur - Velhe Road, Tal - Bhor, Dist - Pune, Pune, IN-MH 412205, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Inito Fertility Monitor Strips; Inito Fertility Test Strips

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2024-07-02

Official Correspondent

Amrut Kare

US Agent Details

Lilian Llull Email: Lilian@Techlinkusa.Net Phone: (305) 2066777

Related Public Records

Same Entity

IMMUNOSCIENCE INDIA PVT. LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031699317. Last updated year: 2026. Please use registration number 3031699317 when referencing this establishment in official correspondence.
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